Ketogenic Diet Variations for Type 2 Diabetes and Obesity
(KETO-IM Trial)
Trial Summary
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Keto-CAN, Ketogenic Diet with Canola Oil, KETO-Can, Keto-SAT, Ketogenic Diet High in Saturated Fat, KETO-Sat, Traditional Ketogenic Diet, LFD, Low-Fat Diet for Type 2 Diabetes and Obesity?
Research suggests that ketogenic diets can be beneficial for weight loss and glucose control in people with diabetes, as seen in older patients where 54% achieved better glucose control and 79% lost weight. Additionally, a low-carbohydrate, ketogenic diet may improve blood sugar levels and reduce the need for diabetes medications.12345
Is the ketogenic diet generally safe for humans?
Based on available evidence, a well-formulated ketogenic diet does not appear to have major safety concerns for the general public and can be considered a first-line approach for obesity and diabetes. However, some adverse events like changes in cholesterol levels, constipation, and fatigue have been reported, so it's important to monitor health while on the diet.13567
How is the Keto-CAN and Keto-SAT treatment different from other treatments for type 2 diabetes and obesity?
The Keto-CAN and Keto-SAT treatments are unique because they are variations of the ketogenic diet, which is high in fat and low in carbohydrates, designed to induce ketosis (a state where the body burns fat for fuel). Keto-CAN uses canola oil, which is high in polyunsaturated fats, potentially offering better insulin sensitivity and lipid profiles compared to traditional saturated fat-rich ketogenic diets like Keto-SAT. This approach contrasts with low-fat diets, which have been less effective in managing obesity and diabetes.12568
What is the purpose of this trial?
The goal of this clinical trial is to compare a healthy KETO diet supplemented with canola oil (KETO-Can) compared to a traditional KETO diet high in saturated fat (KETO-Sat) and low-fat diet (LFD) in adults at high risk of or diagnosed with type 2 diabetes. The main question\[s\] it aims to answer are:* Effects on CVD risk factors (plasma cholesterol, TG, ApoB100, glucose, insulin and HbA1C).* Effects on systemic inflammation and immune function.* Adherence to interventions.Participants will be randomized into 1 of the dietary treatments during which they will follow a Keto or a low-fat diet.Comparisons among groups at 3 and 6 months of intervention will be conducted.
Research Team
Catherine Chan, PhD
Principal Investigator
University of Alberta
Eligibility Criteria
This trial is for adults with obesity or overweight and HbA1C levels at or above 5.7%, indicating high blood sugar, which can be a sign of prediabetes or diabetes. It's not suitable for individuals with certain cholesterol or triglyceride disorders, those undergoing menopause, on dialysis, transitioning transgender individuals, pregnant women, or anyone whose diet wouldn't allow them to follow the study's nutritional guidelines.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized into one of three dietary treatments (KETO-Can, KETO-Sat, or LFD) and receive nutrition counseling for 6 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Keto-CAN
- Keto-SAT
- LFD
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor